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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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Regulators at the European Medicines Agency (EMA) have released the results of an assessment undertaken after an inspection of California-based Pacira Pharmaceuticals uncovered good manufacturing practice violations and sterility issues.

The assessment pertains to a single drug, DepoCyte (cytarabine), used to treat patients with lymphomatous meningitis, a rare peripheral cancer affecting the spinal cord and brain tissue.

EMA officials said they had inspected Pacira's San Diego-based DepoCyte facility in July 2012, where they found, "Deficiencies in the manufacturing process of DepoCyte, relating to a lack of adequate sterility assurance."

Though officials said they have not confirmed any instances in which a non-sterile DepoCyte product has reached patients, they said the findings posed a "theoretical risk of sterility failure," and were recommending EU Member States recall the drugs if alternate treatments were available. In countries where no alternative exists, regulators said the drug may still be used, but should have close patient monitoring to ensure no unexpected adverse events occur.

Until EMA regulators have re-inspected the plant, new batches of DepoCyte will not be manufactured or released, EMA said.